Adrestia Acquired by Insmed Incorporated, Bringing its Novel Approach to Tackling Intractable Genetic Diseases to Insmed’s Early-Stage Research Portfolio

—Insmed to Establish UK Innovation Center to Scale Up Target Discovery Platform and Drive Pipeline of Potentially First-in-Class and First-in-Disease Programs—

CAMBRIDGE, UK. [03 August]. Adrestia Therapeutics, a leader in synthetic rescue therapies for genetic diseases, today announced that it was acquired in June of 2023 by Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. The transaction brings Adrestia’s leading expertise in disease biology and drug discovery to Insmed’s growing bench of early-stage research platforms and its global research, development, and commercial infrastructure.

“Adrestia and its scientific founders have demonstrated that blue-sky thinking, coupled with the latest molecular biology tools and human genetics datasets, can systematically reveal new ways of treating serious diseases,” said Robert Johnson, former Chief Executive Officer of Adrestia and Cambridge Site Head for Insmed. “Our acquisition by Insmed enables us to scale up our research beyond what was possible as a standalone company. With Insmed, we’re no longer dreaming big, we’re going big.”

Adrestia’s synthetic rescue platform uses whole genome assays to identify drug targets for genetic diseases in a wide network of functionally connected genes. The aim is to correct the effects of the causative mutations and ‘rescue’ health. Adrestia was co-founded by Professor Sir Steve Jackson and Ahren Innovation Capital. Sir Steve is FRS, FMedSci, University of Cambridge Professor of Biology and Senior Group Leader at the Cancer Research UK Cambridge Institute. He co-originated the first synthetic lethality drug for cancer and subsequently translated his experience into synthetic rescue tools and technologies focused on novel targets for genetically defined diseases. Synthetic rescue principles are applicable across a wide range of therapeutic modalities, including small molecules, oligonucleotides, and gene therapies.

Since its co-founding by, and seed funding from, Ahren and Series A financing from Ahren and GSK, Adrestia has deepened its unique synthetic rescue capabilities and platform. In applying synthetic rescue principles to the entire human genome, Adrestia has achieved identification of targets with potential applicability in various serious and rare diseases. Adrestia has also established a multi-project discovery collaboration with GSK and cofounded an ataxia-telangiectasia research consortium with leading patient advocacy groups, both of which continue under Insmed.

“Insmed is building a robust engine for medical innovation by bringing together some of the most promising technologies in drug discovery today, and we are proud to add Adrestia and its synthetic rescue expertise to our mission,” said Will Lewis, Chair and Chief Executive Officer of Insmed. “Adrestia’s platform is highly complementary to our existing work in gene therapy, bioinformatics, and drug target identification, and our teams share a strong, patient-centered culture.”

Alice Newcombe-Ellis, General Partner of Ahren added, “Ahren was established to help enable great scientific and tech founders to achieve their visions, while changing the world for the better. We are delighted to have co-founded a company with Sir Steve that might not have otherwise existed and supported him, Rob, and team to this terrific outcome for the company and for patients.”

At the closing of the transaction, Insmed issued 3,430,867 shares of the Company’s common stock to Adrestia’s former shareholders. The closing share price on the date of the transaction was $21.10, resulting in a purchase price of $72.4 million. Former Adrestia shareholders may also become entitled to receive contingent payments up to an aggregate of $326.5 million in cash upon the achievement of certain development, regulatory, and commercial milestone events, as well as royalty payments based upon a low single-digit percentage of net sales of certain products, both subject to the terms and conditions of the agreement.

Adrestia’s operations remain in Cambridge, UK, where the subsidiary now operates under the name Insmed Innovation UK Limited.

J.P. Morgan Securities plc acted as exclusive financial adviser to Adrestia, and Goodwin Procter (UK) LLP acted as Adrestia’s legal counsel.

About Adrestia and Insmed

Adrestia, now operating as Insmed Innovation UK Limited, is a leader in synthetic rescue therapies for genetically defined diseases. Adrestia was co-founded by Professor Sir Steve Jackson and the deep technology investment fund Ahren Innovation Capital.

Adrestia is part of Insmed Incorporated, a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Insmed’s first commercial product is a first-in-disease therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company is also progressing a robust pipeline of investigational therapies targeting areas of serious unmet need, including neutrophil-mediated inflammatory diseases and rare pulmonary disorders. Insmed is headquartered in Bridgewater, New Jersey, with a footprint across Europe and in Japan. For further information, visit: www.insmed.com.

Forward-looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. “Forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “intends,” “potential,” “continues,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company’s current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to obtain, or delays in obtaining, regulatory approvals for ARIKAYCE outside the U.S., Europe or Japan, or for the Company’s product candidates in the U.S., Europe, Japan or other markets, including separate regulatory approval for the Lamira^® Nebulizer System in each market and for each usage; failure to successfully commercialize ARIKAYCE, the Company’s only approved product, in the U.S., Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain U.S., European or Japanese approval for ARIKAYCE; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; impact of the COVID-19 pandemic and efforts to reduce its spread on the Company’s business, employees, including key personnel, patients, partners and suppliers; risk that brensocatib or TPIP does not prove to be effective or safe for patients in ongoing and future clinical studies, including, for brensocatib, the ASPEN study; uncertainties in the degree of market acceptance of ARIKAYCE by physicians, patients, third-party payors and others in the healthcare community; the Company’s inability to obtain full approval of ARIKAYCE from the U.S. Food and Drug Administration, including the risk that the Company will not successfully or in a timely manner complete the study to validate a patient reported outcome tool and the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE; inability of the Company, PARI or the Company’s other third-party manufacturers to comply with regulatory requirements related to ARIKAYCE or the Lamira^® Nebulizer System; the Company’s inability to obtain adequate reimbursement from government or third-party payors for ARIKAYCE or acceptable prices for ARIKAYCE; development of unexpected safety or efficacy concerns related to ARIKAYCE, brensocatib, TPIP or the Company’s other product candidates; inaccuracies in the Company’s estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP or the Company’s other product candidates or in data the Company has used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; the risks and uncertainties associated with, and the perceived benefits of, the Company’s secured senior loan with certain funds managed by Pharmakon Advisors, LP and the Company’s royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the perceived impact of the restrictions on the Company’s operations under these agreements; the Company’s inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of the Company’s product candidates that are approved in the future; failure to obtain regulatory approval to expand ARIKAYCE’s indication to a broader patient population; risk that the Company’s competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product the Company is developing for a particular indication; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP and the Company’s other product candidates due to the Company’s limited experience in conducting preclinical development activities and clinical trials necessary for regulatory approval and its potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; risks that the Company’s clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to manufacture sufficient quantities of ARIKAYCE or the Company’s product candidates for commercial or clinical needs, to conduct the Company’s clinical trials, or to comply with the Company’s agreements or laws and regulations that impact the Company’s business or agreements with the Company; the Company’s inability to attract and retain key personnel or to effectively manage the Company’s growth; the Company’s inability to successfully integrate its recent acquisitions and appropriately manage the amount of management’s time and attention devoted to integration activities; risks that the Company’s acquired technologies, products and product candidates are not commercially successful; the Company’s inability to adapt to its highly competitive and changing environment; risk that the Company is unable to maintain its significant customers; risk that government healthcare reform materially increases the Company’s costs and damages its financial condition; deterioration in general economic conditions in the U.S., Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting the Company, its suppliers, third-party service providers and potential partners; the Company’s inability to adequately protect its intellectual property rights or prevent disclosure of its trade secrets and other proprietary information and costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on the Company by agreements related to ARIKAYCE or the Company’s product candidates, including its license agreements with PARI and AstraZeneca AB, and failure of the Company to comply with its obligations under such agreements; the cost and potential reputational damage resulting from litigation to which the Company is or may become a party, including product liability claims; risk that the Company’s operations are subject to a material disruption in the event of a cybersecurity attack or issue; business disruptions or expenses related to the upgrade to the Company’s enterprise resource planning system; the Company’s limited experience operating internationally; changes in laws and regulations applicable to the Company’s business, including any pricing reform, and failure to comply with such laws and regulations; the Company’s history of operating losses, and the possibility that the Company may never achieve or maintain profitability; goodwill impairment charges affecting the Company’s results of operations and financial condition; inability to repay the Company’s existing indebtedness and uncertainties with respect to the Company’s ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans.

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company’s forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company’s business, please see the factors discussed in Item 1A, “Risk Factors,” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and any subsequent Company filings with the Securities and Exchange Commission (SEC).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contacts:

Media

Tom Donovan

tom@lyrebird.bio

+ 44 7498 152764